FDA 483 - Aurobindo Pharma Limited - September 01, 2017

An FDA inspection of Aurobindo Pharma Limited, Unit VI, located in Hyderabad, Telangana, India, occurred from August 28 to September 1, 2017. The inspection resulted in a Form FDA 483, citing significant observations related to the company's manufacturing and process control systems, indicating a lack of adherence to Good Manufacturing Practices. A primary issue identified was the absence of adequate written procedures for production and process controls, particularly concerning desiccant management and visual inspection for defects. This deficiency directly led to 20 customer complaints across multiple drug product lots, where black desiccant particles were found in containers. Investigations by the firm identified equipment as the likely cause, yet its continued use was noted. Additionally, the FDA observed that control procedures were insufficient to validate manufacturing process performance. Specifically, the company failed to maintain validated 'hold times' for in-process materials. Both Tablets USP and Suspension USP batches manufactured between September 2015 and August 2017 consistently exceeded their maximum validated hold times. These observations necessitate prompt corrective actions to ensure drug product quality and purity, and to validate critical manufacturing parameters to achieve regulatory compliance.